Surgical access system

ABSTRACT

The invention is directed to a surgical access system that provides access to a surgical area while maintaining pneumoperitoneum during laparoscopic surgery. The access system comprises a sheath retractor adapted to dilate a wound stretchable to a desired diameter and a detachable seal adapted to be removable from the sheath retractor. In another aspect, the detachable seal comprising a valve including a plurality of overlapping sheets defining an access channel that extends into communication with the incision in the patient. Each of the overlapping sheets includes a portion of the perimeter that is not fixed to the inner diameter of the ring, which provide open edges defining the access channel.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a continuation application of U.S. patent application Ser. No.11/245,709, filed Oct. 7, 2005, which is a continuation of U.S. patentapplication Ser. No. 10/927,551, filed Aug. 25, 2004, which is acontinuation of (1) PCT application Serial No. PCT/US2004/005484,entitled “Sealed Surgical Access Device,” filed on Feb. 25, 2004, (2)PCT application Serial No. PCT/US2004/005487, entitled “Wound Retractorfor Use in Hand-Assisted Laparoscopic Surgery,” filed on Feb. 25, 2004,and (3) PCT application Serial No. PCT/US2004/005361, entitled“Apparatus and Method for Illuminating a Peritoneal Cavity DuringLaparoscopic Surgery,” filed on Feb. 24, 2004, all of which claimpriority to (4) provisional application Ser. No. 60/449,857, filed onFeb. 25, 2003, entitled “Hand-Assisted Laparoscopy Apparatus andMethod,” all of which are fully incorporated herein by reference intheir entireties.

BACKGROUND

This invention generally relates to surgical access systems thatfacilitate sealed access across a body wall and into a body cavityduring a laparoscopic surgical procedure.

During laparoscopic surgery, it is desirable to inflate the abdominalcavity in order to increase the volume of the working space. This isaccomplished with an insufflation gas which must be maintained at apressure sufficient to inflate the abdomen. Maintaining the pressure ofthe insufflation gas is difficult when it is also desirable to insertinstrumentation through the abdominal wall. If a surgeon is interestedin inserting his or her hand in a hand-assisted laparoscopic procedure,the maintenance of insufflation pressure is even more difficult.Currently, several devices exist that accomplish this surgical needalthough they suffer from drawbacks such as difficult placement andcumbersome use. For example, these hand-assisted devices requireelaborate mechanisms such as inflatable cuffs and adhesives to sealaround a surgeon's wrist or forearm to maintain the insufflation gases.As such, there is a need for a special seal formed around the wrist orforearm of a surgeon to prevent the escape of insufflation gases.Moreover, it is desirable that the wound be retracted, protected andfixed while maintaining the insufflation seal.

SUMMARY

The invention is directed to a hand access system that provides handaccess to a surgical area while maintaining pneumoperitoneum duringlaparoscopic surgery. The hand access system comprises a sheathretractor adapted to dilate a wound stretchable to a desired diameter,the sheath retractor includes a first ring being adapted for dispositioninteriorly of the wound, a second ring being adapted for dispositionexteriorly of the wound, and a sheath being disposed in a generallycylindrical form between the first ring and the second ring and operableto exert a radial retraction force on the wound. The hand access systemfurther comprises a detachable hand seal adapted to be attached anddetached from the second ring of the sheath retractor. In particular,the hand seal can be detached from the sheath retractor to convert thehand access system from laparoscopic surgery to open surgery. In oneaspect, the first ring, second ring and sheath are formed from anelastomeric material, and the hand seal is formed of a gel material andincludes a slit providing an instrument seal in the presence of aninstrument or hand and a zero seal in the absence of the instrument orhand. The gel material includes, for example, a thermoplastic base suchas Kraton® and an oil. The resulting elastomer has excellent tearstrength, elongation greater than 1,000 percent, a very low durometer orhardness, and biocompatibility. It is appreciated that the first ringhas a first diameter and the second ring has a second diameter, and thefirst and second diameters are greater than the desired diameter of thewound.

In another aspect, the sheath retractor further comprises a third ringdisposed circumferentially of the sheath and moveable between aplurality of positions between the first ring and the second ring, eachof the positions being associated with a different retraction force, thethird ring being adapted for disposition exteriorly of the wound. Thesheath retractor may further comprise means for retaining the third ringat one of the plurality of positions in order to provide the desiredradial retraction force associated with that position. The retainingmeans may comprise a fourth ring adapted to interlock with the thirdring to fix the sheath at the desired position. The retaining means mayinclude a wedge disposed between the third ring and the fourth ring.

In yet another aspect of the invention, the hand access system mayfurther comprise an adapter having a first adapter cavity for releasablyattaching to a ring of the retractor sheath and a second adapter cavityfor releasably attaching to the hand seal. The first adapter cavity hasa first diameter and the second adapter cavity has a second diameter.

In other aspects of the invention, the hand seal may include a cavity toreceive the second ring of the sheath retractor, the hand seal mayfurther comprise a latch on an inner diameter for latching the thirdring, and the third ring may comprise at least a hook to latch the handseal as the hand seal is attached to the sheath retractor. To facilitatesealing of the peritoneum, a conformable gasket may be provided that maybe attached to the first ring or to the sheath of the sheath retractor,or the conformable gasket may float unattached to the sheath andinteriorly of the wound.

In another aspect of the invention, the hand access system may comprisea detachable iris seal in place of the hand seal that is adapted to beattached and detached from the sheath retractor. The iris seal comprisesa first iris ring, a second iris ring coaxially attached to the firstiris ring, and a cylindrical elastic member connected to the first andsecond iris rings and having an opening. With this aspect, the first andsecond iris rings operate to rotate relative to one another in eitherdirection to open or close the opening of the cylindrical elasticmember. More specifically, the first and second iris rings may berotated in opposite directions to create an airtight constriction in themiddle of the elastic member. After rotation, at least one of the firstand second iris rings may be de-rotated to loosen or enlarge theconstriction of the elastic member.

Each of the iris rings may comprise a plurality of tracks to allow theiris rings to be relatively rotated at predetermined angles. In yetanother aspect, the iris seal may further comprise a spring connectingthe first and second iris rings to further facilitate a completeopening, a partial constriction or an airtight constriction of theopening of the elastic member. The spring operates to automatically pulland rotate the iris rings after de-rotation. In particular, as an objectis withdrawn from the iris seal, the spring contracts and causes thesheath constriction to tighten automatically. The spring may be formedfrom an elastomeric material. It is appreciated that the amount thespring stretches and contracts is determined by the length of thespring. Each of the iris springs may comprise a hollow frame and aplurality of interlocking tracks. The interlocking tracks operate toencase the spring to prevent the spring from crossing into an instrumentor hand passage area within the iris rings. The interlocking tracks alsooperate to open and close the seal at predetermined angles.

In another aspect of the invention, there is disclosed a surgical accessdevice adapted for disposition relative to an incision in a patientcomprising a valve including a plurality of overlapping sheets definingan access channel, and a ring having an inner diameter for holding thevalve by fixing each of the overlapping sheets along a portion of theperimeter, the access channel extends into communication with theincision in the patient. With this aspect, each of the overlappingsheets includes a portion of the perimeter that is not fixed to theinner diameter of the ring. It is appreciated that the non-fixedportions provide open edges defining the access channel. In one aspect,the open edges slightly overlap for about 0.25″ at the center of thering. The hand access device may further comprise a septum seal formedat the proximal end and at the distal end of the ring, the septum sealhaving a hole formed at the center of the seal. It is furtherappreciated that the open edges of the non-fixed portions may havedifferent shapes including at least one of a straight edge, concave,convex and a cross-configuration.

In yet another aspect of the invention, there is disclosed a surgicalaccess device adapted for disposition relative to an incision in apatient comprising a plurality of septum layers each having a hole atthe center of the septum layer and a first diameter, a ball sandwichedbetween the septum layers and having a second diameter greater than thefirst diameter, and a ring having an inner diameter for affixing theplurality of septum layers along the perimeter. In another aspect, asurgical access device facilitating a sealing relationship with aninstrument or an arm of a surgeon extending through the device and intoan incision in a patient is disclosed, the access device comprising avalve structure including a plurality of overlapping sheets defining anaccess channel, the valve in a first state forming a zero seal in theabsence of the instrument or the arm of the surgeon extending throughthe valve structure, the valve in a second state forming an instrumentseal in the presence of the instrument or the arm of the surgeonextending through the valve structure, and the access channel extendsinto communication with the incision in the patient.

These and other features of the invention will become more apparent witha discussion of the various embodiments in reference to the associateddrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are included in and constitute a partof this specification, illustrate the embodiments of the invention and,together with the description, explain the features and principles ofthe invention. In the drawings:

FIG. 1 is a perspective view showing a patient prone on an operatingtable with his abdomen insufflated and with instrument access providedby trocar and the access device of the present invention;

FIGS. 2A and 2B illustrate a perspective view and a cross-sectionalview, respectively, of a hand access system in accordance with a firstembodiment of the invention;

FIGS. 3A-3E illustrate axial perspective views and cross-sectional viewsof a hand access system in accordance with another embodiment of theinvention including a one-way mechanism;

FIGS. 4A and 4B illustrate cross-sectional views of a hand access systemin accordance with another embodiment of the invention including anadapter;

FIGS. 5A-5C illustrate an axial perspective view and cross-sectionalviews of a hand access system in accordance with another embodiment ofthe invention including a conformable gasket;

FIG. 6 illustrates a cross-sectional view of a hand access system inaccordance with another embodiment of the invention including an irisseal;

FIGS. 7A-7E illustrate the rotation of the iris seal rings of theinvention to create an airtight constriction in the middle of thesheath;

FIGS. 8A-8C illustrate side views of another embodiment of the iris sealincluding a spring connecting the two rings;

FIG. 9 illustrates a top view of FIG. 8B;

FIGS. 10 and 11 illustrate perspective and top views of rings of an irisseal having interlocking tracks in accordance with another embodiment ofthe invention;

FIG. 12 illustrates a perspective view of a hand-assisted laparoscopicseal formed by overlapping sheets of elastomeric material in accordancewith another embodiment of the invention;

FIG. 13 illustrates a perspective view of a hand-assisted laparoscopicseal formed by differently shaped overlapping sheets of elastomericmaterial in accordance with another embodiment of the invention;

FIGS. 14 and 15 illustrate perspective views of a hand-assistedlaparoscopic seal formed by overlapping sheets of elastomeric materialhaving concave and convex configurations;

FIG. 16 illustrates a perspective view of a hand-assisted laparoscopicseal formed by overlapping sheets of elastomeric material including acentral patch supported by spokes in accordance with another embodimentof the invention; and

FIG. 17 illustrates a perspective view of a hand-assisted laparoscopicseal formed by two septum layers sandwiching a ball in accordance withanother embodiment of the invention.

FIGS. 18A and 18B illustrate cross-sectional and perspective views of anaccess system in accordance with an embodiment of the invention.

DETAILED DESCRIPTION

Referring to FIG. 1, there is shown a typical abdominal surgery on apatient 10 in a prone position on an operating table 12. FIG. 1 furtherillustrates a surgeon having an arm 16 and a hand 17 performing thesurgery. In the illustrated example, the operative procedure isperformed within an abdominal cavity 18 with instrument access providedthrough an abdominal wall 21. In this type of operation, commonlyreferred to as laparoscopic surgery, trocars 23 and 25 are commonly usedto provide minimally invasive access through the abdominal wall 21 forinstruments such as a grasper 27 and an endoscope 30. In addition, it isdesirable that the surgeon be able to insert his/her hand 17 through theabdominal wall 21 and into the abdominal cavity 18. The insertion of thehand 17 provides the surgeon with direct access to various elements ofthe anatomy.

In order to accommodate the hand 17 and arm 16 of the surgeon, a smallincision 32 is typically created in the abdominal wall 21. An accessdevice 34 of the present invention can be provided to further facilitatethis access by the hand 17 of the surgeon. Particularly in the case oflaparoscopic surgery, it is advantageous to insufflate the abdominalcavity 18 with a gas, such as carbon dioxide, in order to elevate theabdominal wall 21 and thereby increase the volume of the working spacewithin the cavity 18. Maintenance of this insufflation pressure,commonly referred to as pneumoperitoneum, is particularly difficultwhere access is desired across the abdominal wall 21, for example,through the trocars 23, 25, as well as the access device 34. For thisreason, a substantial effort has been directed to providing such accessdevices with sealing characteristics both in the presence of instrumentsand in the absence of instruments, such as the grasper 27, scope 30 andhand 17.

Were it not for the desire to maintain the pneumoperitoneum, there wouldbe no need for the trocars 23, 25 or the access device 34. That is, onewould merely cut an incision in the abdominal wall 21 and insert theinstrument directly through the incision. However, without appropriatevalves or seals, the insufflation gases would merely escape through theincision 32. This would be particularly detrimental in the case of theincision 32 which must be sufficiently large to accept the hand 17 ofthe surgeon. Thus, the access device 34 operates to form with theincision 32 to provide an access or working channel, and to provide avalve or other sealing structure across the working channel in order tomaintain the pneumoperitoneum.

Referring to FIGS. 2A and 2B, there are shown a perspective view and across-sectional view, respectively, of a hand access system 100 of theinvention. The hand access system 100 provides hand access to a surgicalarea such as the abdominal cavity 18 while maintaining pneumoperitoneumduring laparoscopic surgery. The hand access system 100 comprises asheath retractor 110 including a peritoneal ring 112, a proximal ring114, and a sheath 116 extending along an axis 117 connecting theperitoneal ring 112 and the proximal ring 114. The sheath 116 has agenerally cylindrical configuration that may be retracted to protect anincision within a body cavity such as the abdominal wall 21. Theperitoneal ring 112 and proximal ring 114 are disposed in respectiveplanes which extend radially of the axis 117. The hand access system 100further comprises a detachable hand seal 120 that is operably attachableand detachable to the proximal ring 114 of the sheath retractor 110 asillustrated in FIG. 2B to permit insufflation. It is appreciated thatthe hand seal 120 can be separated from the sheath retractor 110 toallow removal of large organs or to provide open access to the abdominalcavity 18. Stated another way, the hand seal 120 can be removed at anytime to allow conversion from laparoscopic surgery to open surgery.

It is further appreciated that wound retraction in accordance with thepresent invention allows a surgeon to easily locate the sheath retractor110 and to provide a base for the hand seal 120. The sheath retractor110 operates to remove the tissue pressure from the wrist duringhand-assisted laparoscopic surgery. The sheath retractor 110 furtherprotects tissue at the wound site, for example, from abrasion, bacteriaor other contaminated organs, such as donor kidneys to be removed withminimal risk or damage. The sheath retractor 110 also opens the woundproviding greater access to the operative site for instruments, such asthe hand of the surgeon. In particular, the sheath protector 110includes the sheath 116 having elastomeric properties that separate thetwo rings 112, 114. During surgery, the peritoneal ring 112 is placedinteriorly of the abdominal wall 21 and the proximal ring 114 is placedexteriorly of the abdominal wall 21 and is then stretched beyond itsnatural state. The diameters of the rings 112, 114 are greater than thatof the wound site so as to provide sufficient footing and tensionbetween the rings 112, 114. This tension is created by the elasticmaterial that has been stretched and retained at a distance greater thanits natural state. It will be appreciated that in other embodiments, thesheath 116 can be formed of a non-elastic sheathing material. In asimilar manner, the rings 112, 114 may be provided with a rigidconfiguration or alternatively may be formed of an elastomeric material.

Referring to FIGS. 3A and 3B, there are shown perspective views of ahand access system 100 b where elements of structure similar to thosepreviously described are designated by the same reference numeralfollowed by the lower case letter “b” in accordance with anotherembodiment of the invention. The sheath retractor 110 b comprises aperitoneal ring 112 b, a proximal ring 114 b, a sheath 116 b extendingalong an axis 117 b connecting the peritoneal ring 112 b and theproximal ring 114 b, and a one-way mechanism 118 b (a cylindrical plug)that is placed to extend above the incision. More specifically, theone-way mechanism 118 b is placed between the peritoneal ring 112 b andthe proximal ring 114 b. The hand access system 100 b further comprisesa “plug” hand seal 120 b that is operably attached to the proximal ring114 b of the sheath retractor 110 b. The hand seal 120 b can be made ofa soft gel material including a slit providing an instrument seal in thepresence of an instrument or hand and a zero seal in the absence of aninstrument or hand. The gel material includes, for example, athermoplastic base such as Kraton® and an oil. The resulting elastomerhas excellent tear strength, elongation greater than 1,000 percent, avery low durometer or hardness, and biocompatibility.

Referring to FIGS. 3C-3E, there are shown axial perspective views of anexemplary embodiment of the one-way mechanism 118 b of the invention.Specifically, the one-way mechanism 118 b comprises two complimentaryinterlocking rings 83 and 90. The proximal ring 114 b can be disposedoutwardly of the sheath 116 b and the locking ring 90 can be disposedinwardly of the sheath 116 b. These two rings 114 b and 90 function toclamp the sheath 116 b so that the ring 83 is maintained in a fixedposition by the locking ring 90. The interlocking rings 83, 90 of FIG.3C provide for simple operation of the sheath retractor 110 b. Theseinterlocking rings 83, 90 can be pushed down so that they rest on theouter surface of the abdominal wall 21. As the sheath 116 b is drawnupwardly to achieve the proper degree of tension, it is easily movedbetween the interlocking rings 83, 90. However, any tendency of thissheath 116 b to move back into the wound site will tighten theinterlocking relationship of the rings 83, 90. Thus, the desired degreeof tension is maintained on the sheath 116 b until it is again pulled torelease the locking ring 90 from the ring 83.

The one-way characteristics of the interlocking rings 83, 90 are furtherillustrated in the progressive views of FIGS. 3D and 3E. With referenceto these figures, it can be seen that retraction is maintained bypreventing the sheath 116 b from pulling back into the wound by means ofthe one-way operation of the interlocking rings 83, 90. The sheath 116 bslides easily through the interlocking rings 83, 90 in the upperdirection, but is prevented from sliding through the rings 83, 90 in thedownward direction. In order to disengage or separate the interlockingrings 83, 90, one needs only re-tension the sheath 116 b by pulling itproximally thereby unlocking the rings 83 and 90. This enables the ring83 to be removed from the sheath 116 b in order to remove the retractor116 b from the wound site.

In another aspect of the invention, FIGS. 4A and 4B illustrate axialperspective views of a hand access system 100 c comprising a sheathretractor 110 c, an adapter 140 and a detachable hand seal 120 c. Thesheath retractor 110 c includes a peritoneal ring 112 c, a proximal ring114 c, and a sheath 116 c extending along an axis 117 c connecting theperitoneal ring 112 c and the proximal ring 114 c. The adapter 140comprises a first or lower ring 142 for attaching to the proximal ring114 c of the sheath retractor 110 c, and a second or upper ring 144 forattaching to the detachable hand seal 120 c. FIG. 4B illustrates thehand access system 100 c with the sheath retractor 110 c, the adapter140 and the hand seal 120 c installed. More specifically, the adapter140 is first attached to the proximal ring 114 c of the sheath retractor110 c. In turn, the hand seal 120 c may be attached and detached fromthe upper ring 144 of the adapter 140 as needed.

It is appreciated that the proximal ring 114 c may further include amovable ring, which together with the proximal ring 114 c, may be usedto press down on the adapter 140 against the abdomen, for example, tosecure it and form an airtight connection. It is further appreciatedthat the upper ring 144 may have a diameter that is greater than, equalto or less than the diameter of the lower ring 142. In another aspect ofthe invention, the adapter 140 may further comprise grooves to snap in aself-closing iris seal to gain pneumoperitoneum.

FIGS. 5A-5C illustrate perspective and cross-sectional views of a handaccess system 100 d in accordance with yet another embodiment of theinvention where elements of structure similar to those previouslydescribed are designated by the same reference numeral followed by thelower case letter “d”. The hand access system 100 d comprises a sheathretractor 110 d and a hand seal 120 d operably attached to the sheathretractor 110 d. The sheath retractor 110 d includes a peritoneal ring112 d, a proximal ring 114 d, a sheath (not shown) connecting theperitoneal ring 112 d and the proximal ring 114 d, and a one-waymechanism 118 d comprising a plurality of interlocking rings 83 d, 90 d.The hand seal 120 d operably attaches to the proximal ring 114 d of thesheath retractor 110 d. The hand seal 120 d may be formed of a soft gelmaterial and includes a small slit to allow passage of a hand or asurgical instrument during surgery. Referring to FIG. 5B, there is showna cross-sectional view of the hand seal 120 d having a cavity 125 dinside the gel to receive the proximal ring 114 d of the sheathretractor 110 d. Referring to FIG. 5C, the hand seal 120 d may furthercomprise a latch 121 d on an inner diameter for latching the one-waymechanism 118 d. The access sheath material may be placed inside oroutside of the hand seal 120 d after attachment of the hand seal 120 dand the seal retractor 110 d.

In another aspect, the one-way mechanism 118 d may include hooks tolatch the hand seal 120 d as the seal 120 d is pressed down on the openend of the sheath. As explained above, the hand seal 120 d includes asmall slit in the gel that will not allow air to pass with the absenceof an instrument or hand, but the slit will stretch and the gel willcompress to allow objects to pass through with little loss ofpneumoperitoneum. Compression of the gel onto the proximal ring 114 d ofthe sheath retractor 110 d creates an airtight connection. The sheathretractor 110 d, as illustrated in FIG. 5A, may further include aconformable gasket 123 d to facilitate sealing of the peritoneum. Theconformable gasket 123 d on the peritoneum ensures an airtight sealinside the incision as opposed to outside the incision. The gasket 123 dcan be attached to the peritoneal ring 112 d or the sheath 116 d, or itcan float unattached to the sheath. The floating gasket 123 d is lesslikely to crease or bunch (a path for air leaks) as the abdominal wall21, sheath 116 d and peritoneal ring 112 d distort as the sheath 116 dis pulled up into the incision. Without the need for sealing externallyon the skin surface, the conformable gasket 123 d is not susceptible toair leaks from irregularities on the skin, such as scars or folds.Furthermore, the conformable gasket 123 d protects the abdominal wall 21from potential traumatic pressure or abrasion by the peritoneal ring 112d.

In all of the above embodiments of the invention, the ability to attachand detach the hand seal from the sheath retractor allows larger objectsto pass unfettered through the incision. In addition, the invention iseasy to use, it provides increased comfort for the surgeon, and is lesstraumatic to tissue being passed through the incision. For example, thelatching or interlocking feature of the hand seal and the adapter withthe sheath retractor makes it fast and simple to use compared to othermethods that may involve inflatable cuffs or adhesives. Adhesives oftenrequire time to cure and inflation with pumps also creates delay.

In another aspect of the invention, the hand access system may comprisea sheath retractor and an iris seal directly connected to the sheathretractor to form a continuous, seamless sheath. Referring to FIG. 6,there is shown a hand access system in accordance with anotherembodiment of the invention including an iris seal 200. The iris seal200 comprises a first ring 202, a second ring 204 coaxially attachableto the first ring 202, and a cylindrical elastic member 206 connected tothe first and second rings 202, 204 and having an opening. The first andsecond rings 202, 204 operate to rotate relative to one another ineither direction to open or close the opening of the cylindrical elasticmember 206. In particular, the seal 200 operates like the iris apertureof a camera, except that the iris seal 200 is made of a thin film sheathor elastic member 206. A ring 202, 204 is attached to each end of thesheath or elastic sheath 206. Referring to FIGS. 7A-7C, the rings 202,204 are rotated in opposite directions to create an airtightconstriction in the middle of the sheath or elastic member 206. Theconstriction is maintained as long as the rotation is not undone (termedde-rotation). The sheath or elastic member 206 can be made of an elasticmaterial, which allows objects small in diameter relative to the rings202, 204 to pass easily through the constriction without the need forde-rotation. However, objects with large diameters may requirede-rotation to loosen or enlarge the constriction in the sheath asillustrated in FIG. 7D. Once an object is withdrawn, the rings 202, 204must rotate back to create the airtight constriction as illustrated inFIG. 7E. In another aspect, the rings 202, 204 may include a pluralityof tracks 207 such that they may be relatively rotated to open or closethe opening at predetermined angles as further discussed below andillustrated in FIG. 10. More specifically, the sectional area of theopening changes in response to the predetermined angle rotation of therings.

Referring back to FIG. 6, the iris seal 200 may be attached to a sheathretractor 110 f having a peritoneal ring 112 f, a proximal ring 114 f, asheath 116 f connecting the peritoneal ring 112 f and the proximal ring114 f, and a one-way mechanism 118 f (comprising a plurality ofinterlocking rings 83 f, 90 f). A feature of the iris seal 200 is itsconstriction can be dilated as wide as the retracted incision and, assuch, it may not be necessary for it to be detached from the sheathretractor 110 f. In this case, the iris seal 200 can be made a permanentpart of one of the interlocking rings of the one-way mechanism 118 f.Thus, the self-closing iris seal 200 and sheath retractor 110 fcombination allows pneumoperitoneum to be regained more quickly withouthaving to detach and reattach a seal as with previous methods. Inanother aspect, as shown in FIGS. 18A-18B, an iris seal can be easilyremoved when constructed as part of a two-ring design in the form of awedge clamp similar to that shown in FIGS. 3C-3E. Pulling up on a sheathpushes or un-wedges the seal out of the sheath retractor.

It is appreciated that other hand seals can be used and interchanged ascontemplated by the concept of the invention. For example, the iris sealof the invention may further include a spring 208 connecting the firstand second rings 202, 204 to further facilitate the opening and closingof the opening of the cylindrical elastic member 206. More particularly,one or more springs 208 may be used to connect the first and secondrings 202, 204 to provide a complete opening, a partial constriction oran airtight constriction of the iris seal. Referring to FIGS. 8A-8C,there are shown perspective views of the iris seal 200 c of theinvention further comprising the spring 208 connecting the first andsecond rings 202 c, 204 c. FIG. 9 is a top view of the iris seal 200 cof FIG. 8B.

As illustrated in FIGS. 8 and 9, as the rings 202 c, 204 c are rotatedrelative to one another, the spring 208 expands and contracts causingopening and constriction of the seal. More specifically, the spring 208can be used to pull and rotate the rings 202 c, 204 c automaticallyafter de-rotation, for example. The ends of the spring 208 are connectedto the rings 202 c, 204 c in a manner such that de-rotation causes thespring 208 to stretch as illustrated in FIGS. 8A and 8B. Afterwards, thespring 208 contracts and causes the sheath constriction to tightenautomatically as large objects are withdrawn (FIG. 8C). The amount thespring 208 stretches and contracts is determined by the length of thespring 208—typically larger objects require longer springs. Longersprings, however, may crossover the area within the rings 202 c, 204 cand interfere with the passage of objects as illustrated in FIG. 9. Tolimit interference and to accommodate large objects, longer springs canbe housed partially within a series of interlocking tracks 207 of hollowframe rings 202 d, 204 d as illustrated in FIGS. 10 and 11. Inparticular, the interlocking tracks 207 on the rings can encase longersprings so they do not cross into the passage area. The interlockingtracks 207 also operate to open and close the seal at predeterminedangles. FIG. 11A illustrates an axial cross-sectional view of the sealwith the springs contracted and the iris closed, and FIG. 11Billustrates an axial cross-sectional view of the seal with the springsexpanded and the iris opened.

An advantage of rotational adjustment, versus fixed rings, is that awider range of object sizes can easily pass through the iris seal. Aself-closing mechanism of the invention has the advantage of hands-freeadjustment. In comparison to other self-closing methods that involvegears and springs that are connected to stationary components externalto the iris seal, the spring(s) of the present invention are connectedto and contained within the rings, which are integral to the iris seal.With the self-closing mechanism built in, the iris seal is portable andcan be more easily adapted to a wide range of access ports, woundretractors and the like.

In another aspect of the invention, a hand-assisted laparoscopy seal 300is formed by overlapping several sheets 302, 304, 306, 308, 310, 312 ofelastomeric material as illustrated, for example, in FIG. 12. Each ofthese sheets 302, 304, 306, 308, 310, 312 is fixed along a portion ofits perimeter to the circumference of a semi-rigid or rigid ring (notshown). As a result, each of the sheets 302-312 has at least a portion302 a, 304 a, 306 a, 308 a, 310 a, 312 a of its perimeter fixed to thering and a portion 302 b, 304 b, 306 b, 308 b, 310 b, 312 b not fixed tothe ring. These non-fixed portions 302 b-312 b provide open edges withinthe area of the ring. The sheets 302-312 are laid on top of one anotherand are rotated so that open edges extend along different planes. Theseopen edges slightly overlap, such as approximately one-quarter inch, atthe center of the ring to prevent leakage of the insufflation gas.During operation, an instrument or hand of the surgeon is introducedthrough the center of the ring forcing the open edges to part, but alsocausing the open edges to form a sealing structure around the forearm orwrist.

It is appreciated that in the above aspect, the overlapping sheets 302,312 may comprise two septum sheets having their full perimeters fixed tothe ring and a hole formed at the center of the septum sheets. Referringto FIG. 13, there is shown another aspect of the invention where theopen edges 404 b, 406 b, 408 b, 410 b have different shapes, which whenlaid on top of one another, tend to form overlapping sections of acircle. It is appreciated that the concept of the invention contemplatesany number of overlapping sheets of any material and of any shape. Inone simple embodiment, for example, the invention contemplates twosemi-circular sheets having slightly straight overlapping edges.

In another aspect, FIGS. 14 and 15 show how the open edges can beprovided with concave or convex configurations. The sheets or layershaving convex open edges 506, 510, 608, 610 tend to flex more while thesheets or layers having concave edges 504, 508, 604, 606 tend to givemore support. The septum sheets or layers 502, 602 provide the mostsupport. Other shapes can be used for the layers as illustrated in theembodiment of FIG. 16 where one of the layers includes a central patch704 supported by spokes 704 a, 704 b, 704 c, 704 d which extend to thering. The central patch 704 is large enough to cover the hole 702 a inthe septum layer 702. In the embodiment of FIG. 17, two septum layers802, 806 sandwich a ball 804 which is movable within the confines of thering. The ball 804 has a diameter greater than the holes 802 a, 806 a inthe septum layers 802, 806, respectively.

It will be understood that many other modifications can be made to thevarious disclosed embodiments without departing from the spirit andscope of the invention. For these reasons, the above description shouldnot be construed as limiting the invention, but should be interpreted asmerely exemplary of the disclosed embodiments.

The invention claimed is:
 1. A surgical access system, comprising: asheath retractor adapted to dilate a wound stretchable to a desireddiameter, the sheath retractor disposed in a generally cylindrical formand operable to exert a radial retraction force on the wound; and aniris seal removably coupled to the sheath retractor, the iris sealcomprises: a first iris ring; a second iris ring coaxially attached tothe first iris ring; and a spring connected to and biasing the first andsecond iris rings; an elastic member connected to the first and secondiris rings and defining an opening, wherein the first and second irisrings operate to rotate relative to one another in either direction toopen or close the opening of the elastic member, each of the iris ringscomprises a plurality of interlocking tracks to allow the iris rings tobe relatively rotated at predetermined angles.
 2. The surgical accesssystem in claim 1 wherein the spring automatically pulls and rotates theiris rings after de-rotation.
 3. The surgical access system in claim 1wherein the spring is formed from an elastomeric material.
 4. Thesurgical access system in claim 1 wherein as an object is withdrawn fromthe iris seal, the spring contracts and causes the elastic member totighten automatically and wherein an amount the spring stretches andcontracts is determined by the length of the spring.
 5. The surgicalaccess system in claim 1 wherein each of the iris rings comprises ahollow frame and the plurality of interlocking tracks encases the springto prevent the spring from crossing into an instrument or hand passagearea within the iris rings.
 6. The surgical access system in claim 1wherein each of the iris rings comprises a hollow frame and theplurality of interlocking tracks operate to open and close thecylindrical elastic member at predetermined angles.
 7. The surgicalaccess system of claim 1 wherein the plurality of interlocking tracks onthe first iris ring comprises a first track disposed near an outerperiphery of the first iris ring and a second track disposed near aninner periphery of the first iris ring.
 8. The surgical access system ofclaim 7 wherein the plurality of interlocking tracks on the second irisring are disposed in a middle portion of the second iris ring.
 9. Thesurgical access system of claim 1 wherein the plurality of interlockingtracks on the second iris ring are disposed between the plurality ofinterlocking tracks on the first iris ring.
 10. The surgical accesssystem of claim 1 wherein the plurality of interlocking tracks of atleast one of the first iris ring and the second iris ring includes afirst track encircled by a second track.
 11. The surgical access systemof claim 1 wherein the plurality of interlocking tracks of the firstiris ring includes a first track and a second track, the second trackhaving an opening between first and second ends of the second track. 12.The surgical access system of claim 1 wherein the spring is containedwithin the first and second iris rings.
 13. The surgical access systemof claim 1 wherein the iris seal has an airtight constriction state inwhich the spring is contracted.
 14. The surgical access system of claim13 wherein the iris seal has an open state in which the spring isexpanded and the elastic member has a cylindrical form when the irisseal is completely open.
 15. The surgical access system of claim 1wherein the iris seal is hands-free adjustable and self-closing.
 16. Thesurgical access system of claim 1 wherein the iris seal and the sheathretractor form a sealing relationship with a robotic device or an arm ofsurgeon extending therethrough and into a patient.
 17. The surgicalaccess system of claim 1 wherein the sheath retractor comprises: a firstring being adapted for disposition interiorly of the wound; a secondring being adapted for disposition exteriorly of the wound; and a sheathbeing disposed in a generally cylindrical form between the first ringand the second ring.
 18. The surgical access system of claim 17 whereinat least one of the first ring, the second ring and the sheath is formedfrom an elastomeric material.